Pharmacokinetics of Paracetamol and Antiepileptic Drugs After Sleeve Gastrectomy

Effect of Sleeve Gastroctomy on Pharmacokinetics of Paracetamol and Antiepileptic Drugs

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03161509

Enrollment

Registered

2017-05-19

Start date

2017-07-01

Completion date

2019-01-01

Last updated

2021-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate

Brief summary

Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will measure pharmakokinetics of paracetamol and antiepileptic drugs before and 6 months after sleeve gastrectomy.

Detailed description

Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will measure pharmakokinetics of paracetamol (in consenting subjects that are undergoing sleeve gastrectomy) and antiepileptic drugs (in consenting subjects that are chronically treated by a stable dose) before and 6 months after sleeve gastrectomy in 10 subjects. Blood tests will be taken for drug levels before and 4-8 times after the subject takes the drug. A pharmacokinetic curve will be calculated and compared for each subject between prior to surgery and after surgery.

Interventions

DRUGParacetamol

single dose of 1 gr paracetamol

DRUGAntiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)

Single dose of antiepileptic drug (either carbamazepine, lamotrigine, phenytoin or valproic acid) for which the participant is taking chronically in stable dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

All participants will undergo blood tests for pharmacokinetic of paracetamol before and 6 months after sleeve gastrectomy

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

1. BMI over 30 and eligible for sleeve gastrectomy 2. Mentally capable for consent 3. (for the antiepileptic drug intervention) chronic stable treatment of antiepileptic drug

Exclusion criteria

1. Gastrointestinal illness impairing absorption 2. renal failure (glomerular filtration rate\<45) 3. liver cirrhosis 4. heart failure (New York Heart Association class III or IV)

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic curve of paracetamol or antiepileptic drug: AUC	8 hours	sequential measurement of paracetamol or antiepileptic drug (carbamazepine, lamotrigine, phenytoin or valproic acid), AUC

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026